Advanced Impella SmartAssist System for Subject Monitoring and Treatment: An Early Feasibility Study
||Male and Female Patients
|U.S. Govt. ID:
||Kate Dalton: 347-514-3366 / email@example.com
The purpose of this study is to demonstrate that the Impella Hemodynamic Platform (the StudyDevice) is safe and that measurements obtained are as good as currently used methods. This includes how much pressure the heart is generating and how much blood your heart is pumping during the PCI. PCI is a surgical procedure that uses a catheter (a thin flexible tube) to place a small structure called a stent to open up blood vessels in the heart that have been narrowed by plaque buildup. The TheImpella device will be placed via the a femoral artery and delivers up to 3.5 liters of blood per minute to the heart. During its placement, the Impella CP with SmartAssist is positioned in such a way that will allow for the required measurements.
This study is closed
Jeffrey Moses, MD
|Are you 18 years of age or older?